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Veterinary - Medical Device - Weigh Scale - GMP requirement?

Discussion in 'Medical Devices (21 CFR Part 820)' started by qu1nn, Sep 17, 2015.

  1. qu1nn

    qu1nn New Member

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    Hello,

    The company I work for makes weigh scales in the US.
    Generally the Class 1 medical devices do not require 510k or premarket approval and in general dont even require gmp (ie Product Code FRI). One product type (FRW) requires GMP requirements. Both require standard recall / notification requirements.

    The company has started to branch into weigh scales for veterinary use, and I dont clearly see if there is the GMP requirement.
    From the FDA article : How FDA Regulates Veterinary Devices

    From what I can tell they:
    1) dont need to be registered with the FDA
    2) there is no 510(k) , or premarket approval
    3) It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.

    I have been googling for quite some time and I have not been sucessful in clearly determining if GMP is a requirement in medical weigh scales for animals.
    Any suggestions, guidance, or experience?


    Best Regards,
    Thanks for your time
    Quinn
     
  2. Atul Khandekar

    Atul Khandekar Administrator Staff Member

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    Any help for qu1nn ?
    Thanks.
     
  3. Ronen E

    Ronen E Well-Known Member

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    As far as I know no QMS is formally required for veterinary devices, and the FDA requirements in general are very limited.

    Make sure to check whether any USDA requirements apply.
     
    Atul Khandekar likes this.

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